What the label lists and what reports show
Nitroglycerin side effects
Nitroglycerin's FDA label: “Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia.” FAERS holds 53,311 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (4,297 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the nitroglycerin FDA label on DailyMed (effective February 15, 2023, Viatris Specialty LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NITROSTAT?NITROSTAT may cause the following side effects: • headache • vertigo (a major symptom of balance disorder) • dizziness • weakness • heart palpitations (unusual awareness of the heartbeat) • low blood pressure upon rising from a seated position • nausea and vomiting • sweating • paleness • fainting • flushing (warm or red condition of your skin) • other skin reactions that may be severe Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of NITROSTAT . For a complete list, ask your doctor or pharmacist. How do I store NITROSTAT? NITROSTAT should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency. Store NITROSTAT tablets at room temperature (between 68° and 77°F). […]
Source: FDA drug label, Viatris Specialty LLC, effective February 15, 2023 (SPL set 9a52da75-d0af-4237-96c0-0b12adfa8636), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Nitroglycerin label published by Mylan Pharmaceuticals Inc. of November 3, 2014; the label quoted above does not print one.
| Reaction | Placebo | Patch |
|---|---|---|
| Headache | 18% | 63% |
| Light-headedness | 4% | 6% |
| Hypotension, and/or syncope | 0% | 4% |
| Increased angina | 2% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail elsewhere in the label: • Hypotension [see Warnings and Precautions (5.2) ] • Headache [see Warnings and Precautions (5.4) ] • Hypersensitivity [see Contraindications (4.4) ] Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported. Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy. Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Viatris Specialty LLC, effective February 15, 2023 (SPL set 9a52da75-d0af-4237-96c0-0b12adfa8636), via openFDA; the full label on DailyMed
What do FAERS reports show?
53,311 reports list nitroglycerin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,013 are coded as a death and 24,315 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nitroglycerin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions